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DDD Update

Daily news and top headlines for drug research professionals

Shire Receives Notice Letter from Sandoz

May 20, 2011 11:56 am | News | Comments

Shire LLC has received a Paragraph IV Notice Letter from Sandoz Inc. advising of the filing of an Abbreviated New Drug Application for a generic version of all strengths of VYVANSE.

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Logos and Medidata Partner

May 20, 2011 11:51 am | News | Comments

Medidata Solutions, a leading global provider of SaaS-based clinical development solutions, announced London-based Logos Technologies as a Medidata Technology Partner.

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Stem Cell PCR Kit

May 20, 2011 11:47 am | Product Releases | Comments

AMSBIO has announced the launch of the PluriPCR Kit, a new benchmark to revolutionize the definition of stem cell pluripotency. The PluriPCR kit has been designed as a quantitative and reliable assay of five genes strongly specific to pluripotency.

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Roller Bottle

May 20, 2011 11:41 am | Drug Discovery & Development | Product Releases | Comments

Greiner Bio-One North America, Inc. now offer the Cellmaster Roller Bottle product portfolio, designed to fulfill different requirements for the production of virus vaccines or recombinant proteins used for therapeutic approaches.

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Regulators OK Extended Patient Treatment

May 20, 2011 11:34 am | News | Comments

TxCell SA announces the approval by AFSSAPS, the French regulatory agency, of its application to extend treatment of patients included in the Crohn’s Disease phase 1/2 study with Ovasave, a type 1 regulatory T cell based immunotherapy.

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TM-400 Granted Orphan Drug Status

May 20, 2011 11:28 am | News | Comments

TikoMed AB announced that TM-400 has been granted orphan drug designation for treatment to mobilize progenitor cells prior to stem cell transplantation by the European Medicines Agency.

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Pfizer's Eliquis Approved in Europe

May 20, 2011 11:24 am | News | Comments

Drugmaker Pfizer said that European regulators have approved its highly-anticipated blood thinner Eliquis to prevent blood clots in patients who have had hip or knee replacement surgery.

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EMA Panel Recommends Victrelis Approval

May 20, 2011 11:21 am | News | Comments

Drugmaker Merck & Co. said that a European drug agency has endorsed its hepatitis C treatment Victrelis, also known as boceprevir - a key step toward possible approval in the European Union.

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FDA Approves New HIV Drug

May 20, 2011 11:19 am | News | Comments

The Food and Drug Administration said it approved a new HIV drug from Johnson & Johnson for patients who have not been treated with other medications for the virus.

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Pearl Therapeutics Study Shows Lung Function Improvement

May 20, 2011 6:21 am | News | Comments

Pearl Therapeutics Inc. presented efficacy and safety results in the company's Phase 2b study of PT003 (GFF MDI) in patients with moderate-to-very severe COPD at the annual meeting of the American Thoracic Society (ATS).

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Safety Committee Reports Findings on Gardasil

May 20, 2011 6:16 am | News | Comments

An independent safety review committee reported study findings on nearly 190,000 females who received at least one dose of Merck’s Gardasil, a quadrivalent human papillomavirus vaccine (qHPV) at two managed care associations between August 2006 and March 2008.

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Eli Lilly Names Senior Medical Advisor

May 20, 2011 6:12 am | News | Comments

David M. Kendall, MD, currently chief scientific and medical officer of the American Diabetes Association, has been named distinguished medical fellow for Lilly.

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Late-Stage Fluorination Company Secures Funding

May 20, 2011 6:08 am | News | Comments

SciFluor Life Sciences  has secured $5 million in first-round funding from Allied Minds for a technology that enables late-stage fluorination of pharmaceutical drug candidates and other commercial chemicals.

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Study Questions Ezetimibe Benefits

May 20, 2011 6:03 am | News | Comments

While physicians routinely prescribe statin therapy combined with ezetimibe for some patients with high cholesterol., a study by University of Virginia Health System researchers adds to mounting evidence that ezetimibe may not stop significant artery wall thickening, or atherosclerosis, in some patients.

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Packaging Process for Genes Discovered

May 20, 2011 5:56 am | News | Comments

Penn State University scientists have assembled entire chromosomes from their component parts in a test tube, an achievement that reveals the process a cell uses to package the basic building blocks of an organism's genome.

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